510(k) · Cleared
ClearedMiniox 3000 Oxygen Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minesafety Appliances Co. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Jul 25, 1996 as substantially equivalent to K833326 (Catalyst Research Corp., 1983) after an 87-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.
- Decided
- Jul 25, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833326 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK833326 Mini OX Iii Oxygen MonitorCatalyst Research Corp. · 1983
- This deviceK961644 Miniox 3000 Oxygen MonitorMinesafety Appliances Co. · 1996
- Descendant · cites it directly · 0 of its ownK991884 Siemens FIO2 SensorSiemens Medical Solutions USA, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK971084 Model 02 Oxygen AnalyzerOxigraf, Inc. · 1998
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833326 | Mini OX Iii Oxygen Monitor | Catalyst Research Corp. | 1983 | — |
| 0 (this device) | K961644 | Miniox 3000 Oxygen Monitor | Minesafety Appliances Co. | 1996 | — |
| +1 | K991884 | Siemens FIO2 Sensor | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +1 | K971084 | Model 02 Oxygen Analyzer | Oxigraf, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CCL device
- #1 K261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K833326 | Mini OX Iii Oxygen MonitorSummary page 2…ygen Monitor COMMON NAME: Oxygen monitor CLASSIFICATION NAME: Oxygen gas analyzer (868.1720) MARKETED DEVICE: MiniOX® lil Oxygen Monitor Mine Safety Appliances Company (K833326) DEVICE DESCRIPTION Battery operated and microprocessor controlled, the MiniOX® 3000 Oxygen Monitor measures oxygen concentrati… | 1983 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CCL devicesCCL Analyzer, Gas, Oxygen, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCL
Too few CCL 510(k)s in any year since 2007 to give a median.
Recalls per year · CCL
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCL
2in 2025
MAUDE reports naming product code CCL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MiniOX® 3000 Oxygen Monitor provides continuous, direct monitoring of oxygen mixtures in a wide variety of medical applications such as anesthesiology (e.g., anesthesia machines), respiratory therapy (e.g., respirators, ventilators, pediatric incubators), and oxygen therapy (e.g., oxygen tents). The MiniOX® 3000 Oxygen Monitor is to be used by trained health care professionais under the supervision, or on the order, of a physician in a hospital (or other clinical setting) and during emergency transport.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961644: Miniox 3000 Oxygen Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961644
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026